Ari Shika's Blog

Posting what I notice day by day. Please visit my "JP Blog" https://ameblo.jp/arishika18/

"Is a formal application for approval of gene injection accepted? "


"Is a formal application for approval of gene injection accepted? "


Current gene injections (commonly known as gene vaccines) are temporarily approved for emergency use and are not officially approved by government authorities.


On May 7, 2021, Pfizer apparently filed an application (Biologics License Application) to obtain formal FDA certification.


The Phase 3 clinical trial (two-year plan) is still in the process of only six months.


Even the fastest approved vaccine to date has averaged 23 months since the start of clinical trials.


If the FDA officially approves gene injections, it will be a big break and a new world record (^ _−) − ☆.


Why did you apply for formal approval when only 6 months had passed?


This situation is excellent for answering the question of Peter Doshi, the editor-in-chief of the British Medical Journal, which I introduced in my book "The Truth about Vaccines" and "The Second Volume Where Viruses Do Not Exist". I would like to introduce the paper that was published (Covid-19 vaccines: In the rush for regulatory approval, do we need more data? BMJ 2021; 373: n1244 | doi: 10.1136 / bmj.n1244) ..


As I mentioned in my article last year, there was concern in clinical trials that the placebo group might receive a gene injection at the start and promotion of gene injection last year.


If people in the placebo group receive a gene injection through government and media promotion (now a chance! (^ _-)-☆), the placebo group is virtually in Phase 3 clinical trials. It will disappear.


This means that Phase 3 clinical trials will virtually disappear.


This concern is also addressed in this issue of Mr. Dosi.


And what ...


In response to the question to Modena, Pfizer, Johnson & Jyonson, "How many people in the placebo group in clinical trials have already been vaccinated with genes?"


Modena honestly replied, "I recommended my vaccine to everyone in the placebo group and 98% of them got it!"


OMG!


Pfizer, Johnson & Jyonson declined to answer in detail, but they probably gave everyone in the clinical trial their own gene injections to eliminate the placebo group, as originally planned.


Therefore, the “should” Phase 3 clinical trials with results next year have already been eliminated.


Furthermore, when applying for approval of a new drug, it is necessary to submit data on the biodistribution of the drug when it enters the body. However, no research data has been submitted for this gene injection (Neither Pfizer nor Modena responded).


Perhaps the true picture of modern medicine was glimpsed during the great transformation of this era (^ _−) − ☆?